EP3661494A1 - Verwendung von tasimelteon zur behandlung von affektiven störungen - Google Patents

Verwendung von tasimelteon zur behandlung von affektiven störungen

Info

Publication number: EP3661494A1
Authority: EP; European Patent Office
Prior art keywords: patient; tasimelteon; day; effective amount; administering
Prior art date: 2017-08-02
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.): Granted

Application number

EP18755664.2A

Other languages

English (en)

French (fr)

Other versions

EP3661494B1 (de

EP3661494B8 (de

Inventor

Mihael Polymeropoulos

Christos POLYMEROPOULOS

Changfu XIAO

Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)

Vanda Pharmaceuticals Inc

Original Assignee

Vanda Pharmaceuticals Inc

Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)

2017-08-02

Filing date

2018-08-02

Publication date

2020-06-10

2018-08-02 Application filed by Vanda Pharmaceuticals Inc filed Critical Vanda Pharmaceuticals Inc

2020-06-10 Publication of EP3661494A1 publication Critical patent/EP3661494A1/de

2023-10-11 Publication of EP3661494B1 publication Critical patent/EP3661494B1/de

2023-11-22 Application granted granted Critical

2023-11-22 Publication of EP3661494B8 publication Critical patent/EP3661494B8/de

Status Active legal-status Critical Current

2038-08-02 Anticipated expiration legal-status Critical

Links

Classifications

- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/34—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide
- A61K31/343—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having five-membered rings with one oxygen as the only ring hetero atom, e.g. isosorbide condensed with a carbocyclic ring, e.g. coumaran, bufuralol, befunolol, clobenfurol, amiodarone
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/24—Antidepressants

Definitions

Affective disorders are mood disorders and include, among other disorders, depressive disorders.
Illustrative affective disorders include attention deficit hyperactivity disorder (ADHD), bipolar disorder, body dysmorphic disorder, bulimia nervosa and other eating disorders, cataplexy, dysthymia, generalized anxiety disorder, hypersexuality, irritable bowel syndrome (IBS), impulse-control disorders, kleptomania, migraine, major depressive disorder (MDD), obsessive-compulsive disorder (OCD), oppositional defiant disorder, panic disorder, post- traumatic stress disorder (PTSD), premenstrual dysphoric disorder, social anxiety disorder, and fibromyalgia.
ADHD attention deficit hyperactivity disorder
bipolar disorder bipolar disorder
body dysmorphic disorder bulimia nervosa and other eating disorders
cataplexy dysthymia
generalized anxiety disorder hypersexuality
IBS irritable bowel syndrome
IBS irritable bowel syndrome
impulse-control disorders
disorders may be part of a spectrum accompanying or associated with affective disorders. These include, for example, chronic pain, intermittent explosive disorder, pathological gambling, personality disorder, pyromania, substance abuse and addiction including alcoholism, and trichotillomania.
Depressive disorders affect nearly 20 million adults in the US and are characterized by an array of symptoms, including persistent sad, anxious, or empty mood; feelings of hopelessness or pessimism; feelings of guilt, worthlessness, or helplessness; loss of interest or pleasure in hobbies and activities that were once enjoyed, including sex; decreased energy, fatigue, or a feeling of being "slowed down;” difficulty concentrating, remembering, or making decisions; insomnia, early- morning awakening, or oversleeping; appetite and/or weight loss; overeating and weight gain; thoughts of death or suicide; suicide attempts; restlessness or irritability; and persistent physical symptoms that do not respond to treatment, such as headaches, digestive disorders, and chronic pain. Untreated depressive disorders may be both emotionally and physically debilitating.
MDD Major depressive disorder
dysthymia dysthymia
bipolar disorder also referred to as manic-depressive illness
MDD is manifested by a combination of symptoms that interfere with one's ability to work, study, sleep, eat, and enjoy once-pleasurable activities. MDD may occur only once, but more commonly occurs several times during a patient's lifetime. MDD is often associated with insomnia and it has been hypothesized that circadian rhythm disruption may be involved in the etiology of MDD. Dysthymia is typically less severe than MDD and involves long-term, chronic symptoms that do not disable but prevent one from functioning well or feeling well. Patients with dysthymia may also experience episodes of MDD at times.
Bipolar disorder is not as common as other depressive disorders and is characterized by mood changes between severe highs (manic episodes) and severe lows (depressive episodes). Mood changes may be rapid and dramatic, but are more typically gradual.
a depressive episode an individual may experience any or all of the symptoms of other depressive disorders.
a manic episode an individual may be overactive, overly talkative, and have a lot of energy.
Manic episodes often affect thinking, judgment, and social behavior that result in embarrassment or other problems. Untreated, manic episodes may worsen to a psychotic state.
Tasimelteon (?r «5-N-[[2-(2,3-dihydrobenzofuran-4-yl)cycloprop-lyl]methyl] propanamide) is a circadian regulator which binds specifically to two high affinity melatonin receptors, Mel la (MT1R) and Mel lb (MT2R). These receptors are found in high density in the suprachiasmatic nucleus of the brain (SCN), which is responsible for synchronizing our sleep/wake cycle.
SCN suprachiasmatic nucleus of the brain
Tasimelteon is disclosed in US Patent No. 5,856,529 and US Patent Application Publication No. 2009/0105333. Tasimelteon improves sleep parameters in clinical studies which simulate a desynchronization of the circadian clock. Tasimelteon has so far been studied in hundreds of individuals and is shown a good tolerability profile.
An individual with genetic "Majority Black African” ancestry refers to an individual having ancestry in any of the black African populations that is about 50% or greater black African ancestry. This definition encompasses individuals, for example, with about 50% or 70% or greater West African ancestry. African- Americans, as that term is used here, is defined as a subpopulation of Americans who are "Majority Black African.” In this regard, Bryc et al., for example, report that, on average, African- American populations comprise 73.2-82.1% West African, 16.7-24% European, and 0.8-1.2% Native American genetic ancestry, although there is large individual variation. SUMMARY
Embodiments of the invention relate generally to the treatment of an affective disorder in individuals of Majority Black African genetic ancestry, including African- Americans by administering to the patient an amount of tasimelteon effective to treat such disorder.
tasimelteon is administered: at a dose of 20 mg/day, prior to bedtime (e.g., 0.5 hour to 2 hours prior), under fasted conditions, while avoiding the coadministration of rifampicin, while avoiding the coadministration of fluvoxamine, while avoiding administration to a patient who smokes, to a patient having high or low endogenous melatonin, or any combination thereof.
the treatment of an affective disorder in a Majority Black African (including African- American) patient includes entraining the patient's circadian rhythm, melatonin rhythm, and/or Cortisol rhythm to a 24-hour sleep-wake cycle by administering to the patient an effective amount of tasimelteon.
HAMD Hamilton Depression Scale
An analysis by reported race however, reveals a significant positive effect of tasimelteon among African- American patients.
166 32.7%) are African- American, of which 78 received tasimelteon and 88 placebo.
a majority of the remaining patients included in the study are Caucasian.
a responder analysis improvement in the HAMD scale of 50% or greater from baseline
mean MO occurs at 21:07 ⁇ 1:53 hours (range 14:58-01:50 hours).
mean MO occurs at 21:36 ⁇ 1:53 hours (range 16:23-03:54 hours).
Embodiments of the invention therefore include the treatment of an affective disorder in a Majority Black African patient in need of such treatment.
the invention includes treating an affective disorder in a Majority Black African patient by administering to the patient an amount of tasimelteon effective to treat said affective disorder.
Such administration is prior to bedtime, e.g., between about 0.5 hour and about 2 hours prior to a target bedtime.
the amount of tasimelteon effective to treat the affective disorder is between 10 mg/day and 100 mg/day, e.g., between 20 mg/day and 50 mg/day, e.g., 20 mg/day.
a 24-hour sleep- wake cycle is a cycle in which the patient goes to sleep at or near a target bedtime and awakens at or near a target wake time following a daily sleep period of approximately 7 to 9 hours.
These and other embodiments may include administering tasimelteon to a Majority Black African patient after discontinuing the administration of fluvoxamine or rifampicin to said patient, administering tasimelteon to such patient after such patient discontinues smoking, and/ or administering tasimelteon to such patient without food.

Landscapes

Health & Medical Sciences (AREA)
Chemical & Material Sciences (AREA)
Medicinal Chemistry (AREA)
Pharmacology & Pharmacy (AREA)
Life Sciences & Earth Sciences (AREA)
Animal Behavior & Ethology (AREA)
General Health & Medical Sciences (AREA)
Public Health (AREA)
Veterinary Medicine (AREA)
Epidemiology (AREA)
Engineering & Computer Science (AREA)
Chemical Kinetics & Catalysis (AREA)
Pain & Pain Management (AREA)
Bioinformatics & Cheminformatics (AREA)
Biomedical Technology (AREA)
Neurology (AREA)
Neurosurgery (AREA)
Psychiatry (AREA)
General Chemical & Material Sciences (AREA)
Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
Organic Chemistry (AREA)
Nutrition Science (AREA)
Physiology (AREA)
Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

EP18755664.2A 2017-08-02 2018-08-02 Verwendung von tasimelteon zur behandlung von affektiven störungen in mehrheitlich schwarzafrikanische patienten Active EP3661494B8 (de)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
US201762540200P	2017-08-02	2017-08-02
PCT/US2018/044995 WO2019028245A1 (en)	2017-08-02	2018-08-02	USE OF TASIMELTÉON FOR THE TREATMENT OF AFFECTIVE DISORDERS

Publications (3)

Publication Number	Publication Date
EP3661494A1 true EP3661494A1 (de)	2020-06-10
EP3661494B1 EP3661494B1 (de)	2023-10-11
EP3661494B8 EP3661494B8 (de)	2023-11-22

Family

ID=63209730

Family Applications (1)

Application Number	Title	Priority Date	Filing Date
EP18755664.2A Active EP3661494B8 (de)	2017-08-02	2018-08-02	Verwendung von tasimelteon zur behandlung von affektiven störungen in mehrheitlich schwarzafrikanische patienten

Country Status (4)

Country	Link
US (2)	US20210059973A1 (de)
EP (1)	EP3661494B8 (de)
ES (1)	ES2965488T3 (de)
WO (1)	WO2019028245A1 (de)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
CN115401700A (zh) *	2021-05-26	2022-11-29	上海千蝶医学科技有限公司	一种智能护理机器人

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
RU2190609C2 (ru)	1996-12-10	2002-10-10	Бристол-Маерс Сквибб Компани	Производные бензодиоксола, бензофурана, дигидробензофурана и бензодиоксана и содержащие их композиции
US20090105333A1 (en)	2006-05-22	2009-04-23	Gunther Birznieks	Melatonin agonist treatment
WO2007137247A2 (en)	2006-05-22	2007-11-29	Vanda Pharmaceuticals, Inc.	Treatment for depressive disorders
KR102593047B1 (ko)	2012-01-26	2023-10-24	반다 파마슈티칼즈, 인코퍼레이티드.	일주기 리듬 장애의 치료
WO2014100292A1 (en)	2012-12-18	2014-06-26	Vanda Pharmaceuticals Inc.	Treatment of circadian rhythm disorders
US10376487B2 (en)	2013-11-12	2019-08-13	Vanda Pharmaceuticals Inc.	Method of treatment

2018
- 2018-08-02 WO PCT/US2018/044995 patent/WO2019028245A1/en not_active Ceased
- 2018-08-02 EP EP18755664.2A patent/EP3661494B8/de active Active
- 2018-08-02 ES ES18755664T patent/ES2965488T3/es active Active
- 2018-08-02 US US16/636,292 patent/US20210059973A1/en not_active Abandoned
2022
- 2022-05-26 US US17/804,126 patent/US20220280471A1/en not_active Abandoned

Also Published As

Publication number	Publication date
US20220280471A1 (en)	2022-09-08
WO2019028245A1 (en)	2019-02-07
EP3661494B1 (de)	2023-10-11
EP3661494B8 (de)	2023-11-22
US20210059973A1 (en)	2021-03-04
ES2965488T3 (es)	2024-04-15

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